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"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI

NCT07711106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-17

No results posted yet for this study

Summary

This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a "IVUS-trained eye" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability. The primary objective is to compare the planimetric stent appearance between two strategies.

Conditions

  • Coronary Artery Disease (CAD)
  • Chronic Coronary Syndrome
  • Left Main Coronary Artery Disease
  • Coronary Bifurcation Lesion

Interventions

PROCEDURE

IVUS-Guided LM PCI

Coronary stent - single manufacturer and model ("Calypso", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits). Procedure steps: * Baseline IVUS pullback - assessment of proximal and distal reference segments and lesion length * Stent selection based on IVUS data * Stent implantation * Mandatory optimization: kissing balloon dilation; proximal optimization * Final IVUS pullback to confirm result

PROCEDURE

"Trained Eye" (Angiography-Guided) LM PCI

Coronary stent - single manufacturer and model ("Calypso", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits). Procedure steps: * Anatomical assessment based on visual angiographic evaluation * Stent and balloon selection at operator discretion * Stent implantation * Mandatory optimization (same steps: kissing balloon dilation, proximal optimization) * Final IVUS pullback performed only afterward, solely to assess planimetric result (not used to guide the procedure itself)

Sponsors & Collaborators

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-01-01
Completion
2027-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711106 on ClinicalTrials.gov